HOUT-04. ASSOCIATION OF COMMON PATIENT-REPORTED IMMUNOTHERAPY SYMPTOMATIC SIDE EFFECTS AND PSEUDOPROGRESSION IN PATIENTS WITH PRIMARY CENTRAL NERVOUS SYSTEM (CNS) TUMORS

Abstract BACKGROUND Immunotherapy agents have unique symptomatic side effects; patient-reported outcomes (PROs) can help to characterize the benefits and burdens associated with therapy. Common immunotherapy-associated symptoms include pain, fatigue, shortness of breath, and irregular bowel patterns. The purpose of this study was to assess the severity of symptoms and their association with imaging changes in CNS tumor patients undergoing single agent or combination treatment with immune checkpoint inhibitors (ICIs). METHODS Patients completed the MDASI-BT or MDASI-SP at baseline and longitudinally (every 8 weeks), and results through cycle 4 are reported. Neuro-imaging was categorized as stable, possible ICI-related pseudoprogression, or progression by clinical team review. RESULTS 29 Brain Tumor (BT) and 6 Spinal Tumor patients participated; the majority of which were male (62%) and white (91%), ranging 24-74yo (mean = 46). Glioblastoma was the most common diagnosis (31%) followed by medulloblastoma (16%), with 56% of patients having greater than 2 recurrences prior to the study. At baseline, both brain and spine tumor patients reported moderate to severe fatigue (Brain=4, Spine=6) and pain (Spine=5) with shortness of breath and pain worsening over time. BT patients with pseudoprogression were more likely to report increased fatigue (87%) and pain (63%) compared to those with stable (29%) or true progressive (17%) disease on imaging. BT patients with pseudoprogression also reported worsening of cognitive (43%) and neurologic (57%) symptom burden. CONCLUSIONS In contrast to the common pseudoprogression after chemoradiation, treatment-specific symptoms were worse with ICI-related pseudoprogression by MRI where an immunologic reaction was the likely cause of the imaging worsening. These results suggest that commonly used symptom and functional assessments to distinguish true progression from pseudoprogression may not be helpful with immunotherapy. Additional studies including those with pathologic confirmation of progression or pseudoprogression combined with outcomes measures are needed to develop more accurate determinations of disease status.

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QOLP-28. THE USE OF VIRTUAL REALITY FOR SYMPTOM MANAGEMENT: APPLICATION IN NEURO-ONCOLOGY

Neuro-Oncology ◽

10.1093/neuonc/noz175.848 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi203-vi204

Author(s):

Nicole Leggiero ◽

Terri Armstrong ◽

Elizabeth Vera ◽

Mark Gilbert ◽

Amanda King

Keyword(s):

Virtual Reality ◽

Symptom Management ◽

Strong Support ◽

Symptom Burden ◽

High Grade Glioma ◽

Tumor Patients ◽

Cns Tumor ◽

Pain Anxiety ◽

Common Diagnosis ◽

Patient Reported

Abstract Patients with primary central nervous system (CNS) tumors are highly symptomatic due to the functional sequelae of their disease and an unfavorable prognosis. Virtual reality (VR) immersive technology has demonstrated benefit in improving patients’ symptom burden, such as distress, pain, anxiety, and fatigue. However, this has not been explored in a CNS tumor population. This project explored the potential use of VR for symptom management in CNS tumor patients. A descriptive analysis of MDASI-BT/MDASI-SP/PROMIS-Anxiety patient-reported outcomes (PROs) for 535 CNS tumor patients was performed to identify the common moderate-severe (> 4 on a 0–10 scale) symptoms. Additionally, a systematic review of literature was performed addressing the question “For adult patients with solid tumors, what effect does VR have on their self-reported symptoms, such as distress, anxiety and pain?” The systematic literature review resulted in 17 studies using VR in other solid tumor populations, which demonstrated improvement in pain, anxiety, and distress. However, study designs often lacked rigor and none incorporated any biomarkers to correlate with PROs. CNS tumor symptom review of our patient cohort revealed that the majority of the patients were Caucasian (83%) males (58%) with a median age of 50 years (range, 18–83). At the time of diagnosis, 35% had a gross total resection. Glioblastoma was the most common diagnosis (32%) and 50% had a high-grade glioma. The most prevalent moderate-severe symptoms in this sample was fatigue (34%), with (14%) anxiety, (18%) pain, and (19%) distress. Given the high symptom rate in our patients, the promising but limited data that VR technology could improve distress and other symptoms provides strong support for this intervention in the CNS tumor population. Further research is needed to assess feasibility and efficacy of VR, as well as incorporation of correlative biomarkers, to better determine potential improvement in patient symptom burden.

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Symptom Profiles in Patients with Chronic Lymphocytic Leukemia: Validation and Application of the M. D. Anderson Symptom Inventory.

Blood ◽

10.1182/blood.v114.22.1393.1393 ◽

2009 ◽

Vol 114 (22) ◽

pp. 1393-1393

Author(s):

Xin Shelley Wang ◽

Tito R. Mendoza ◽

Jackie B Broadway ◽

Gary M. Mobley ◽

Michael Keating ◽

...

Keyword(s):

Chronic Lymphocytic Leukemia ◽

Symptom Severity ◽

Symptom Burden ◽

Physical Symptoms ◽

Lymphocytic Leukemia ◽

Shortness Of Breath ◽

Symptom Inventory ◽

Symptom Profile ◽

Patient Reported ◽

Symptom Group

Abstract Abstract 1393 Poster Board I-415 Chronic lymphocytic leukemia (CLL) is the most prevalent form of adult leukemia. Patients with CLL have a long life expectancy and little attention has been paid to the symptom burden that accompanies this disease. We, therefore, wanted to explore the reliability and validity of the M. D. Anderson Symptom Inventory (MDASI) in measuring the symptom burden of patients with CLL. The MDASI is an established, reliable and validated tool for assessing cancer-related symptoms regardless of therapy or specific cancer diagnosis.1 The MDASI measures the most common symptoms across most cancer types and treatments: 13 items assess symptom severity at its worst in the last 24 hours and 6 items assess symptom-related interference in the last 24 hours, all rated on a 0–10 numeric scale. These 19 symptom and interference items comprise the “core” MDASI. We enrolled 126 consecutive patients with CLL being followed at our outpatient center. Patients eligible for this study were required to be speak English and have a pathological diagnosis of CLL. A clinical nurse conducted interviews, had patients complete self-administered MDASI, and collected information from patients' medical record. Sixty-three % of the patients were male, 95% were white non-Hispanic, the mean age was 59 years (range 29-79) with 27% of them age 65 years or older. Eighty-three % of the patients had Rai stage 0-2, and 56% were untreated. Factor analysis of the MDASI items resulted in a three-factor solution (physical symptoms, psychological symptoms, and gastrointestinal symptoms), which satisfied criteria for interpretability and model fit in a confirmatory setting. Cronbach coefficient alphas for the MDASI were 0.89 for the symptom severity subscale and 0.94 for the interference subscale. Convergent validity showed that the two MDASI subscales were significantly correlated with similar subscales of the SF-12 (12-Item Short-Form Health Survey). The most severe patient-reported MDASI symptoms were fatigue, disturbed sleep, drowsiness, distress, and difficulty remembering. Patients with poorer performance status (ECOG PS 2 vs. 1 vs. 0) reported significantly higher severity for both core MDASI and total interferences (all P < .001). Patients with higher Rai staging [3-4 vs 0-2] reported significantly higher severity on core symptoms and interferences (P<.01), especially on fatigue, nausea, sleep, shortness of breath, drowsiness (All P<.05), and lack of appetite (P<.001). Older patients (aged 65 years and older) had significantly higher fatigue, shortness of breath, and lack of appetite [P<.001], but lower sadness. We observed that female reported significantly higher pain and sadness (All <.05). Patients with more prior chemotherapy [1 or more vs. 0 cycles chemotherapy) reported significantly higher symptom severity for core items on MDASI [P=.013] and higher symptom interferences [P=.001], especial on fatigue, shortness of breath, and drowsiness (All P<.01). Sixty-one percent of the sample rated at least one symptom as moderate to severe (≥5 on the MDASI's 0–10 scale). In cluster analysis, approximately 30% of patients belonged to the high-symptom group (Fig 1: symptom severity by items on MDASI for both high and low symptom group). The most burdens from symptoms were interference of working, enjoyment of life and activity. In conclusion, our data analysis showed that the MDASI is a reliable and valid tool for assessing symptom severity and interference with daily functioning in patients with CLL. The MDASI symptom profile demonstrated that almost one-third of patients had significantly higher symptom severity. This validated MDASI provides a useful tool for measuring symptom burden and monitor symptom control in patients with CLL. Figure Patient reported symptom severity (0-10 scale) on MDASI: majority of patient (70%) had multiple low symptom profile Figure. Patient reported symptom severity (0-10 scale) on MDASI: majority of patient (70%) had multiple low symptom profile Disclosures: No relevant conflicts of interest to declare.

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Patient-reported symptom burden and quality of life in advanced lung cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e16570 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e16570-e16570

Author(s):

Shrividya Iyer ◽

Alex Rider ◽

Gavin Taylor-Stokes ◽

Adam Roughley

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Performance Status ◽

Symptom Burden ◽

Shortness Of Breath ◽

Patient Reported ◽

And Performance ◽

Loss Of Appetite ◽

Nsclc Patients

e16570 Background: The main objective of our study was to assess patient reported symptom burden and impact on quality of life in advanced non small cell lung cancer (NSCLC) patients in the United States. Methods: Patients with advanced (stage IIIB/IV) NSCLC (N=450) were recruited with informed consent in a nationwide (US) lung cancer study from Oct-Dec 2011. Patient reported symptoms were assessed using the Lung Cancer Symptom Scale (LCSS) on a 0-100 visual analogue scale and included six symptoms: fatigue, appetite loss, shortness of breath, cough, pain and blood in sputum. An average symptom burden index was calculated. Quality of life was assessed using the Functional Assessment of Cancer Therapy- Lung (FACT-L).Higher scores indicate higher symptom severity on the LCSS and better quality of life on the FACT-L. Correlation between the total FACT-L score and LCSS symptom burden index was assessed. A multivariate regression analysis was performed with FACT-L total score as the dependent variable and LCSS symptom scores as predictors controlling for age, gender, stage and performance status. Results: Majority of the patients were male (59%), Caucasian (74%), smokers/ex-smokers (78%) with an average age of 64 years. Proportion of patients reporting each lung cancer symptom was: Fatigue (100%), loss of appetite (97%), shortness of breath (95%), cough (93%), pain (92%) and blood in sputum (63%). The average (SD) symptom burden index was 42.3 (21.5).The mean± SD severity scores on symptoms were: fatigue (53.2±24.7), loss of appetite (48.1±25.8), cough (48.4±29.9), shortness of breath (44.7± 27), pain (39.7± 28.1) and blood in sputum (18.4±23.6). The average (SD) FACT-L score was 71.7 (25.3). A significant negative correlation was found between the LCSS symptom burden index and FACT-L scores (ρ= -0.82; p<0.001). Loss of appetite (β=-0.204; p<0.001), cough (β= -0.145; p<0.01), pain (β=-0.265; p<0.001), shortness of breath (β = -0.145; p<0.01), age (β= 0.217; p<0.05) and performance status (β = 0.283; p<0.001) were found to be significant predictors of quality of life. Conclusions: Cough, pain, shortness of breath and loss of appetite contribute to symptom burden and have a significant negative impact on quality of life in advanced NSCLC patients.

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Immunotherapy releated cardiomyopathy.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e14601 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e14601-e14601

Author(s):

Ozlem Sonmez ◽

Ozlem Nuray Sever ◽

Basak Oyan ◽

Osman Gokhan Demir

Keyword(s):

Side Effects ◽

Checkpoint Inhibitors ◽

Rare Complication ◽

Single Agent ◽

Tnf Alpha ◽

Oncology Practice ◽

And Control ◽

Chemotherapy Agents ◽

As Effects ◽

Cessation Of Treatment

e14601 Background: Side effects of immunotherapies also differ from classical cytoxic chemotherapy agents such as effects. Cardiomyopathy is a relatively rare complication. Studies have shown that the risk of developing myocarditis is higher when the ipilimumab / nivolumab combination is used than when the single agent nivolumab is used. ImmunoCheckpoint inhibitors are associated with an increase in immunologic response and immunosuppressives such as corticosteroids, TNF-alpha antagonists and mycophenolate acetate are used in treatment.In this study, we aimed to report cardiac toxicity in patients who treated with immune checkpoint inhibitors. Methods: Forty patients who were treated with immunocheckpoint inhibitors were screened retrospectively at two centers in Turkey between August 2015 and January 2017 . Results: Twenty-eight of the patients were male (70%), 12 were female (30%); The median age was 61 (32-81) years. 23 (57.5%) patients received nivolumab and 16 (40 %) patients received pembrolizumab and 1(2.5%) patient received pembrolizumab/ipilimumab combination. Seven of the cases had immuno-related side effects (17.5%).In two of our patients, after the second cure of the treatment, diffuse edema and shortness of breath due to heart failure was detected. Echocardiography revealed a low ejection fraction. Methylprednisolone was started by cessation of treatment. One week after the symptoms improved rapidly and control ejection fractions normalized. One of these patients was diagnosed with malignant melanoma and the other with RCC , they using pembrolizumab and nivolumab respectively. Conclusions: In conclusion, side effects that may occur may lead to fatal outcomes, while immunotherapy, which is increasingly used in oncology practice, may result in satisfactory success in treatment. Patients and their relatives should be adequately informed about side effects caused by these agents, complaints should be carefully evaluated and treatment should be started without spending time.

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Addressing risk of financial toxicity in an ambulatory oncology practice: Our institutional experience with the ASCO Quality Training Program.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.114 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 114-114

Author(s):

Thomas A. Hensing ◽

Tyler Bauer ◽

Anna Palafox ◽

Margaret Whalen ◽

George W. Carro

Keyword(s):

Checkpoint Inhibitors ◽

Symptom Burden ◽

Cancer Therapies ◽

Financial Toxicity ◽

Improvement Project ◽

Pareto Chart ◽

Increased Risk ◽

Ambulatory Oncology ◽

Patient Reported ◽

The Impact

114 Background: Due to escalating cost of cancer care, patients (PTs) with cancer are at increased risk for financial toxicity (FTOX) that can exacerbate disparities in care and lead to clinically relevant adverse PT outcomes; including quality of life; symptom burden; adherence; and survival. A review of our informed consent (IC) process demonstrated that PTs were not routinely informed of financial risks of high-cost (HC) cancer therapies at the time of IC. Methods: A multidisciplinary team was formed to conduct a rapid-cycle quality improvement project with the aim of reducing FTOX through improvement in patient education at the time of IC. Because of HC and increased utilization, the initial pilot focused on treatment with immune checkpoint inhibitors (ICI). A cause and effect diagram identified the potential causes that FTOX was not addressed during the IC process. Diagnostic data were obtained through staff surveys and querying our EMR from June to August, 2016. A Pareto chart identified lack of educational (ED) tools at the time of IC and a poorly understood prior authorization (PA) process as the most common causes for not addressing risk of FTOX during IC. Plan-do-study-act (PDSA) #1 began with development of a PT ED tool to be used during IC. The tool was approved by the Patient Advisory Board. Staff from clinical teams utilizing ICI for approved indication completed training on its use and a pilot study was initiated. PDSA#2 focused on optimizing the PA process and PDSA#3 focused on PT distress and FTOX monitoring through the NCCN distress and a validated patient-reported-outcome tools (COST), respectively. Results: The utilization of the PT ED tool reached the project aim (administer to > 65% of pts during IC) during initial phase of PDSA#1, although accrual is ongoing. A revised PA process (PDSA#2) was developed, staff were educated and the updated PA process was initiated. Work on PDSA#3 is ongoing. Conclusions: This QI project suggests that it is feasible to address FTOX through PT ED during IC for HC cancer therapies. However, the impact of this intervention on PT distress, overall FTOX and treatment disparities will need to be monitored closely.

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Utilizing patient reported outcomes for patients recieving oral chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.190 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 190-190 ◽

Cited By ~ 1

Author(s):

Emily R. Mackler ◽

Kathleen W. Beekman ◽

Laura Bushey ◽

Anne Gentz ◽

Kathleen Davis ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Patient Reported Outcomes ◽

Symptom Burden ◽

Symptom Assessment ◽

Oral Chemotherapy ◽

Severe Side Effect ◽

Management Support ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale

190 Background: Management of oral chemotherapy presents many challenges to oncology practitioners. The purpose of this study is to describe how incorporation of patient reported outcomes (PRO) for patients receiving oral chemotherapy can identify those patients who are experiencing moderate to severe symptom burden and nonadherence. Methods: As part of a statewide quality collaborative, we wished to improve our monitoring of patients receiving oral chemotherapy. The quality collaborative created a PRO assessment that includes a revised Edmonton Symptom Assessment Scale (ESAS), a single-item adherence question, reasons for nonadherence, the patient’s most bothersome symptom and questions related to patient confidence. Our medical assistants provide the assessment to the patient before each appointment. Results: Patients completing the PRO during the first 3 months (7/7/16 – 9/27/16) were evaluated. We had 32 assessments completed by 23 patients. The oral chemotherapy prescribed were capecitabine (48%), erlotinib (13%), temozolomide (13%), and not recorded (26%). Of the 29 completed ESAS assessments, 72% included at least 1 moderate side effect, and 48% included at least 1 severe side effect. 29% of patients reported low-moderate confidence to self-manage their symptoms. Less than excellent adherence (<80% adherence) was reported in 30% of patients with the most commonly reported reason being related to side effects or concerns about side effects. Conclusions: Use of PROs in our oral chemotherapy population identified a large proportion of patients experiencing moderate to severe side effects. Further assessment of how this compares to what patients report to their oncologist during their visits will be reviewed. In addition, we found that approximately 30% of our patients are nonadherent to their oral chemotherapy. This is consistent with recent publications. We plan to continue assessing patient outcomes and utilizing the data we collect to improve patient self-management support.

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Follow-Up of Cancer Patients Receiving Anti-PD-(L)1 Therapy Using an Electronic Patient-Reported Outcomes Tool (KISS): Prospective Feasibility Cohort Study (Preprint)

10.2196/preprints.17898 ◽

2020 ◽

Author(s):

Sanna Iivanainen ◽

Tuomo Alanko ◽

Pia Vihinen ◽

Teemu Konkola ◽

Jussi Ekstrom ◽

...

Keyword(s):

Side Effects ◽

Cancer Patients ◽

Prediction Models ◽

Checkpoint Inhibitors ◽

Patient Reported Outcome ◽

Treatment Benefit ◽

Wide Range ◽

Patient Reported ◽

Loss Of Appetite

BACKGROUND Immune checkpoint inhibitors (ICIs) have become a standard of care for various tumor types. Their unique spectrum of side effects demands continuous and long-lasting assessment of symptoms. Electronic patient-reported outcome (ePRO) follow-up has been shown to improve survival and quality of life of cancer patients treated with chemotherapy. OBJECTIVE This study aimed to investigate whether ePRO follow-up of cancer patients treated with ICIs is feasible. The study analyzed (1) the variety of patient reported symptoms, (2) etiology of alerts, (3) symptom correlations, and (4) patient compliance. METHODS In this prospective, one-arm, multi-institutional study, we recruited adult cancer patients whose advanced cancer was treated with anti-programmed cell death protein 1 (PD)- ligand (L)1 agents in outpatient settings. The ePRO tool consisted of a weekly questionnaire evaluating the presence of typical side effects, with an algorithm assessing the severity of the symptom according to National Cancer Institute Common Terminology Criteria for Adverse Events and an urgency algorithm sending alerts to the care team. A patient experience survey was conducted monthly. The patients were followed up to 6 months or until disease progression. RESULTS A total of 889 symptom questionnaires was completed by 37 patients (lung cancer, n=15; melanoma, n=9; genitourinary cancer, n=9; head and neck cancer, n=4). Patients showed good adherence to ePRO follow-up. The most common grade 1 symptoms were fatigue (28%) and itching (13%), grade 2 symptoms were loss of appetite (12%) and nausea (12%), and grade 3-4 symptoms were cough (6%) and loss of appetite (4%). The most common reasons for alerts were loss of appetite and shortness of breath. In the treatment benefit analysis, positive correlations were seen between clinical benefit and itching as well as progressive disease and chest pain. CONCLUSIONS According to the results, ePRO follow-up of cancer patients receiving ICIs is feasible. ePROs capture a wide range of symptoms. Some symptoms correlate to treatment benefit, suggesting that individual prediction models could be generated. CLINICALTRIAL Clinical Trials Register, NCT3928938; https://clinicaltrials.gov/ct2/show/NCT03928938

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Case series on the safety of mRNA COVID19 vaccines in cancer patients undergoing treatment.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e14562 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e14562-e14562

Author(s):

Faysal Haroun ◽

Malak Alharbi ◽

Alison Hong

Keyword(s):

Side Effects ◽

Cancer Therapy ◽

Checkpoint Inhibitors ◽

Performance Status ◽

Single Agent ◽

Case Series ◽

Vaccine Uptake ◽

Cancer Center ◽

High Risk Population ◽

Patients With Cancer

e14562 Background: Millions of vaccines have been administered since Emergency Use Authorization has been granted for two mRNA COVID-19 vaccines (mCV). The Center for Disease Control (CDC) and Prevention recommends that immunocompromised individuals with no contraindications to vaccines may receive an mCV. The CDC suggests that patients receiving cancer therapies should be consulted about the unknown vaccine safety profile and effectiveness. The American Society of Clinical Oncology recognizes that vaccine may reduce the risk of infection for individuals with cancer. Vaccine trials have not actively enrolled immunocompromised or patients on active cancer therapy; therefore, the potential side effects and efficacy of the mRNA vaccines in these individuals are unexplored. Per state guidelines, many patients with cancer undergoing treatment qualify for vaccination however current vaccine uptake in that population is unknown. Data in this specific high-risk population is needed to increase confidence in the vaccine. We explored adverse events (AE) to the mCV in a small cohort of patients undergoing cancer therapy. Methods: Our case series evaluated patients' tolerance to the voluntary but recommended 2 doses of the mCV while on chemotherapy (CX), checkpoint inhibitors (CPI) or tyrosine kinase inhibitors (TKI) at the George Washington University (GWU) Cancer Center in Washington DC. Patient chart review and phone interviews were conducted. Patients had independently signed up for the mCV at the GWU Hospital or through the DC Health Department. Patients were asked if they had experienced any of the commonly reported side effects listed by the CDC or others new symptoms receiving the vaccine. Results: 12 patients had voluntarily received the mCV, all patients were above the age of 65 with a mean age of 72 (66-85). ECOG performance status was 2 or above in 4 patients. 6 patients were receiving single agent CPI, 1 patient was on combination CX and CPI. 2 patients were on oral TKI for EGFR mutated lung cancer. 3 other patients were on combination CX with rituximab, ramucirumab or radiation. In the 2 patients on daily TKI, treatment was not interrupted for the mCV. In the 10 other patients, all but one patient received the mCV at least one week after the last therapy. Both mCV were tolerated without any life-threatening AE or hospitalization. Pain and swelling at the vaccine site were the most common local AE and reported in 7 patients. 6 patients reported systemic AE most commonly myalgia and headaches. Conclusions: This exploratory analysis in 12 patients with cancer undergoing treatment did not uncover any additional SE signals. Larger studies are needed to evaluate AE and efficacy and to guide recommendations for COVID19 vaccination in this patient population.

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A Patient-Reported Outcome Measure for Symptoms and Symptom Burden of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Blood ◽

10.1182/blood.v126.23.2094.2094 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2094-2094 ◽

Cited By ~ 6

Author(s):

Loretta A. Williams ◽

Araceli Garcia-Gonzalez ◽

Hycienth O. Ahaneku ◽

Jorge E. Cortes ◽

Guillermo Garcia-Manero ◽

...

Keyword(s):

Myeloid Leukemia ◽

Research Funding ◽

Outcome Measure ◽

Symptom Burden ◽

Patient Reported Outcome ◽

Shortness Of Breath ◽

Patient Reported Outcome Measure ◽

Disturbed Sleep ◽

Patient Reported ◽

The Mean

Abstract Background: Patient report of disease- and treatment-related symptom burden in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) is scarce. Symptom burden is the combined impact of disease and treatment symptoms on daily functioning. Lack of recognition and monitoring of symptoms and symptom burden can lead to inadequate management and possible treatment non-adherence. Aims: Our aim is to develop a short, valid, reliable patient-reported outcome measure of symptoms and symptom burden experienced by AML and MDS patients and to determine the validity of a single measure for research and practice. Methods: After obtaining IRB approval, patients with AML (N=152) and MDS (N=97) were recruited to this cross-sectional study. Patients rated the 13 core symptom items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, trouble remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness and tingling), 6 proposed AML/MDS symptom items (muscle weakness, malaise, fever, headache, diarrhea, skin problems), and 6 interference items (general activities, mood, work, relations with others, walking, and enjoyment of life) of the MD Anderson Symptom Inventory (MDASI) on 0-to-10 scales (0 = not present or no interference; 10 = as bad as can be imagined or complete interference) twice 1-2 days apart. Clinical and demographic information was collected from medical records and analyzed using descriptive statistics. Means of the symptom and interference ratings for the AML and MDS patients were compared using T-tests. Standard psychometric techniques were used to determine the reliability, stability, and validity of the instrument in patients with AML and MDS. Results: All MDS patients were outpatients while 75 of the AML patients were inpatients and 77 were outpatients. The AML and MDS patients had been diagnosed a mean of 13.8 months (standard deviation [SD]=23.9) and 30.5 months (SD=32.4) respectively. The mean (Mn) symptom and interference ratings respectively for the AML inpatients (Mn=2.8, SD=1.6; Mn=4.0, SD=2.4) were significantly higher than for the AML outpatients (Mn=1.8, SD=1.4, p<0.01; Mn=2.7, SD=2.3, p<0.01) or MDS patients (Mn=1.9, SD=1.5, p<0.01; Mn=2.7, SD=2.5, p<0.01). The mean ratings for the 5 most severe symptom means for AML and MDS patients respectively were: fatigue (Mn=4.0, SD=2.8; Mn=4.0, SD=2.5; p =0.97), disturbed sleep (Mn=3.3, SD=3.2; Mn=2.7, SD=3.3; p=0.19), drowsiness (Mn=3.0, SD=2.8; Mn=2.8, SD=3.1; p=0.70), muscle weakness (Mn=2.9, SD=2.8; Mn=2.9, SD=3.0; p=0.91), dry mouth for AML patients (Mn=3.4, SD=3.2; Mn=2.2,SD=2.8; p<0.01), and shortness of breath for MDS patients (Mn=2.7, SD=2.8; 1.9, SD=2.3; p=0.02). Two of the 6 AML/MDS symptom items (fever and headache) were dropped because so few patients said they experienced the symptoms at more than a mild (0-4 rating) level (12% and 11% respectively). Both groups of patients endorsed similar symptoms, and none of the means of the 4 final AML/MDS symptoms were significantly different between the groups. Cronbach's reliability for all symptom items for AML and MDS respectively were 0.88 and 0.91 and for all interference items were 0.86 and 0.92. The test-retest reliability intra-class correlations were 0.85 for the core symptoms, 0.77 for AML/MDS symptoms, and 0.84 for the interference items. The MDASI-AML/MDS can be completed by patients in less than 5 minutes. Conclusion/Summary: Lack of recognition of symptoms experienced by patients with AML and MDS can lead to inadequate management of symptoms, interfere with the ability of patients to function and enjoy life, and impact the tolerability of and adherence to treatment regimens. While the symptoms experienced by the two groups had some variation in severity, a similar group of symptoms were the most common and relevant for both groups of patients, and the same measure was appropriate for both groups. The MDASI-AML/MDS is a brief, easily-completed, and validated measure of symptom burden for patients with AML and MDS that can be used for accurate and consistent monitoring of symptoms by clinicians and researchers. Disclosures Williams: Amgen: Consultancy; Novartis: Research Funding. Cortes:Pfizer: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BerGenBio AS: Research Funding; Teva: Research Funding; Ariad: Consultancy, Research Funding; Astellas: Consultancy, Research Funding; Ambit: Consultancy, Research Funding; Arog: Research Funding; Celator: Research Funding; Jenssen: Consultancy. Mendoza:Amgen Inc.: Consultancy. Shi:Amgen Inc.: Consultancy. Cleeland:Amgen Inc.: Consultancy.

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Quality of life in long-term survivors of advanced melanoma treated with checkpoint inhibitors

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2019-000260 ◽

2020 ◽

Vol 8 (1) ◽

pp. e000260 ◽

Cited By ~ 2

Author(s):

Maha Mamoor ◽

Michael A Postow ◽

Jessica A Lavery ◽

Shrujal S Baxi ◽

Niloufer Khan ◽

...

Keyword(s):

Quality Of Life ◽

Checkpoint Inhibitors ◽

Symptom Burden ◽

Advanced Melanoma ◽

Life Questionnaire ◽

Patient Reported ◽

Ci Therapy ◽

Long Term Survivors

BackgroundImmune checkpoint inhibitors (CIs) have revolutionized treatment of advanced melanoma, leading to an emerging population of long-term survivors. Survivors’ quality of life (QOL) and symptom burden are poorly understood. We set out to evaluate symptom burden and QOL in patients with advanced melanoma alive more than 1 year after initiating CI therapy.MethodsCross-sectional surveys, accompanied by chart review of patients with advanced melanoma treated with CIs at Memorial Sloan Kettering Cancer Center, completed therapy, and were alive >1 year after treatment initiation. Surveys were administered between February and August 2018. Surveys included: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, EuroQOL, items from Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events and Fatigue Severity Scale.ResultsWe included 90 patients. The most common CI regimens were ipilimumab plus nivolumab (53%) and pembrolizumab (41%); most patients (71%) were not treated in clinical trials. Median time from CI therapy initiation was 40 months and from last dose was 28 months. Fatigue was reported by 28%, with higher fatigue scores in women than men; 12% reported difficulty sleeping. Aching joints (17%) and muscles (12%) were fairly common. Level of functioning was generally high. Overall QOL was excellent though 40% reported ‘some or moderate’ problems with anxiety/depression and 31% with pain/discomfort.ConclusionsAfter CI therapy, long-surviving advanced melanoma patients commonly report fatigue but otherwise have moderate symptom burden and good QOL. Ensuring appropriate symptom management will optimize clinical outcomes for these patients.

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